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FDA accepts BMS’ Opdivo-Yervoy combo sBLA for colorectal cancer
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental biologics licence ...
Targeted Oncology1h
FDA Grants Perioperative Pembrolizumab Priority Review in HNSCC
The FDA granted priority review to pembrolizumab for neoadjuvant and adjuvant use in head and neck squamous cell carcinoma, ...
The Pharma Letter5h
FDA grants priority review to Merck’s sBLA for Keytruda
The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application ...
Cure Today1h
FDA Accepts Priority Review for Pre- and Postsurgical Keytruda in HNSCC
The FDA accepted for priority review a supplemental Biologics License Application for Keytruda for resectable locally ...
Targeted Oncology1d
FDA Accepts sBLA for Nivolumab/Ipilimumab Combo in dMMR/MSI-H CRC
Nivolumab plus ipilimumab is being reviewed by the FDA as a first-line treatment for advanced colorectal cancer, with a ...
2BMY : Bristol Myers Colorectal Cancer Treatment Goes Under Priority FDA Review
Bristol Myers' Opdivo plus Yervoy gets FDA Priority Review for first-line MSI-H/dMMR metastatic colorectal cancer, with a ...
Contract Pharma1d
FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo Plus Yervoy
The application was based on results from the three-arm Phase 3 CheckMate -8HW study.
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SNY and REGN's Dupixent sBLA for Skin Disease Gets FDA's Priority Tag
Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application ...
Press Release: Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid
Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoidIf approved, Dupixent would be the first and only ...
dermatologyadvisor1d
Dupilumab Gets Priority Review for Bullous Pemphigoid
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab to treat adults with bullous pemphigoid.
FDA accepts Bristol Myers’ sBLA for Opdivo plus Yervoy
Squibb announced that the U.S. FDA has accepted the supplemental biologics license application for Opdivo plus Yervoy as a ...
Yahoo Finance7d
SNY and REGN's Dupixent sBLA for Skin Disease Gets FDA's Priority Tag
Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application (sBLA) seeking approval for Dupixent for treating bullous pemphigoid (BP ...